Respiratory Syncytial Virus poses a significant global public health threat, particularly affecting infants aged less than one year of age. Recently, two forms of passive immunization against infant RSV have been developed and brought to market; nirsevimab a long-acting monoclonal antibody (mAb) and RSV-PreF, a maternal RSV vaccine. The acceptability and uptake of these products will play a pivotal role in determining the success of any national immunization strategy aimed at safeguarding infants from RSV. It is crucial at this time to reflect on the factors that influence parental decisions surrounding immunization to facilitate more informed discussions, enhance healthcare communication, and contribute to the design of effective RSV prevention strategies that resonate with the concerns and aspirations of parents worldwide.

2024-11-01·Infectious Diseases and Therapy

Respiratory Syncytial Virus Risk Profile in Hospitalized Infants and Comparison with Influenza and COVID-19 Controls in Valladolid, Spain, 2010–2022

Article

作者: Sanz, Javier Castrodeza ; Domínguez-Gil, Marta ; Eiros, José M ; Rojo-Rello, Silvia ; Mengel, Martin ; He, Yongzheng ; Atwell, Jessica E ; Eiros, José M. ; Uppal, Sonal ; Atwell, Jessica E. ; Toquero-Asensio, Marina ; Fan, Rong ; Hernán-García, Cristina ; Martin-Toribio, Alejandro ; Haeberer, Mariana ; Liu, Qing ; Fernández-Espinilla, Virginia ; Sanz-Muñoz, Ivan

INTRODUCTIONWe aimed to describe the risk profile of RSV infections among children aged ≤ 24 months in Valladolid from January 2010 to August 2022 and to compare them with influenza and COVID-19 controls.METHODSWe conducted a retrospective cohort study of all laboratory-confirmed RSV, influenza, and COVID-19 infections. We analyzed risk factors for RSV hospitalization and severity (length-of-stay ≥ 8 days, intensive-care-unit admission, in-hospital death or readmission < 30 days) and compared severity between hospitalized RSV patients vs. influenza and COVID-19 controls using multivariable logistic regression models.RESULTSWe included 1507 patients with RSV (1274 inpatient), 32 with influenza, and 52 COVID-19 controls. Hospitalized RSV (mean age 5.3 months) and COVID-19 (4 months) were younger than influenza (9.1 months) patients. Sixteen percent of patients had RSV within the first month of life. Most infants did not have comorbidities (74% RSV, 56% influenza, and 69% COVID-19). Forty-one percent of patients with RSV and influenza were coinfected vs. 27% COVID-19 (p = 0.04). Among RSV, hospitalization risk factors were prematurity (adjusted OR 3.11 [95% CI 1.66, 4.44]) and coinfection (2.03 [1.45, 2.85]). Risks for higher severity were maternal smoking (1.89 [1.07, 3.33]), prematurity (2.31 [1.59, 3.34]), chronic lung disease (2.20 [1.06, 4.58]), neurodevelopmental condition (4.28 [2.10, 8.73]), and coinfection (2.67 [2.09, 3.40]). Breastfeeding was protective against hospitalization (0.87 [0.80, 0.95]) and severity (0.81 [0.74, 0.88]), while complete vaccination schedule was protective against severity (0.51 [0.27, 0.97]). RSV had 2.47 (1.03, 5.96) higher risk of experiencing any severe outcome compared to influenza and did not show significant differences vs. COVID-19.CONCLUSIONSRSV hospitalizations were more frequent and severe than influenza, while severity was comparable to the early pandemic COVID-19. Currently, both influenza and COVID-19 vaccines are included in the maternal and childhood Spanish immunization schedule between the ages of 6 and 59 months. RSV monoclonal antibody is recommended for ≤ 6 months but a third of patients were aged 6-24 months. Maternal RSV vaccination can protect their children directly from birth and indirectly through breastfeeding.

2024-09-01·Reviews in Medical Virology

Systematic Review of the Efficacy and Safety of RSV‐Specific Monoclonal Antibodies and Antivirals in Development

Review

作者: Sevendal, Andrea T. K. ; Hurley, Siobhan ; Walker, Gregory J. ; Bartlett, Adam W. ; Rawlinson, William

ABSTRACTRespiratory syncytial virus (RSV) is a leading cause of acute respiratory infection amongst all ages, causing a significant global health burden. Preventative and therapeutic options for RSV infection have long been under development, and recently, several widely‐publicised vaccines targeting older adult and maternal populations have become available. Promising monoclonal antibody (mAb) and antiviral (AV) therapies are also progressing in clinical trials, with the prophylactic mAb nirsevimab recently approved for clinical use in infant populations. A systematic review on current progress in this area is lacking. We performed a systematic literature search (PubMed, Embase, Web of Science, ClinicalTrials.gov, EudraCT, ANZCTR—searched Nov 29th, 2023) to identify studies on all RSV‐specific mAbs and AV therapies that has undergone human clinical trials since year 2000. Data extraction focused on outcomes related to the therapeutic efficacy and safety of the intervention on trial, and all studies were graded against the OCEBM Levels of Evidence Table. Results from 59 studies were extracted, covering efficacy and safety data on six mAbs (motavizumab, motavizumab‐YTE, nirsevimab, ALX‐0171, suptavumab, clesrovimab) and 12 AV therapies (ALN‐RSV01, RSV604, presatovir, MDT‐637, lumicitabine, IFN‐α1b, rilematovir, enzaplatovir, AK0529, sisunatovir, PC786, EDP‐938). Of the mAbs reviewed, nirsevimab and clesrovimab hold considerable promise. The timeline for RSV‐specific AV availability is less advanced, although EDP‐938 and AK0529 have reported promising phase 2 efficacy and safety data. Moving forward, passive immunisation and treatment options for RSV infection will play a significant role in reducing the health burden of RSV, complementing recent advancements in vaccine development.Trial RegistrationPROSPERO registration: CRD42022376633

项与非维珠单抗相关的新闻（医药）

2024-10-25

·BioPharmaDive

Sanofi earnings boosted by Beyfortus, earlier vaccine sales

Sanofi reported a 25% boost in sales for its vaccines division during the third quarter, helped by earlier-than-anticipated orders of its flu shots as well as rising revenue from Beyfortus, its RSV antibody for infants.Announcing earnings Friday, the French pharmaceutical company said Beyfortus sales were 645 million euros, or about $700 million. Overall, Sanofis vaccines unit brought in about 3.8 billion euros, driving total company sales to $13.4 billion.The companys performance beat Wall Street expectations, pushing its share price higher in Friday trading on French and U.S. stock exchanges.We reached almost 16% sales growth in the third quarter, illustrating the underlying strength of our portfolio, said Sanofi CEO Paul Hudson, in a statement. Our performance was boosted by the phasing of flu and Beyfortus, he added.Beyfortus is approved in the U.S. to prevent disease from respiratory syncytial virus infections in infants up to 24 months old who are entering their first RSV season, or who remain vulnerable during their second season. The antibody drug was approved last summer.Recently, Sanofi and its partner AstraZeneca gained regulatory approval for a new manufacturing line to expand supply of the shot Beyfortus. The companies had struggled to keep up with supply during Beyfortus first season on the market, as higher-than-expected demand led to a shortage of its 100 milligram dose for infants weighing 11 pounds or more. The Centers for Disease Control and Prevention responded by recommending doses be prioritized for high-risk infants, and encouraged women who were pregnant to receive Pfizers RSV vaccine Abrysvo, if eligible.Sanofi has said it expects the increased Beyfortus capacity to support access to the drug for every eligible baby in the U.S.The only other available treatment for RSV prevention in infants is the antibody Synagis, but use of that drug is limited to certain high-risk infants. Merck & Co. could soon bring to market another competing antibody called clesrovimab, which it aims to make available for the 2025-2026 RSV season, if approved.The typical RSV season begins in fall and lasts through the winter in the U.S. '

上市批准疫苗

2023-08-04

·BioPharmaDive

RSV antibody from Sanofi, AstraZeneca backed by CDC for use in infants

The Centers for Disease Control and Prevention on Thursday recommended use of a monoclonal antibody to protect infants and some older babies from respiratory syncytial virus, or RSV, endorsing the advice of an expert committee that had backed the drug earlier in the day.Called Beyfortus and developed by partners Sanofi and AstraZeneca, the shot is expected to be available in time for the start of the typical RSV season this fall. It won Food and Drug Administration approval in JulyThe CDC recommends one dose of Beyfortus for all infants under 8 months old who are born during or entering their first RSV season. The agency is also advising that children between 8 months and 19 months who are at increased risk of severe RSV disease receive a dose in their second season.The expert panel, known as the Advisory Committee on Immunization Practices, or ACIP, voted unanimously in support of both uses.We do believe this is a breakthrough, said ACIP chair Sarah Long, a professor of pediatrics at Drexel University College of Medicine and an infectious disease physician.Most infants are likely to be infected by RSV before their second birthday. Typically, the virus causes mild symptoms similar to that of a cold. But it can be more dangerous in some young babies, and is the leading cause of hospitalization for infants under one year old. Several hundred children under 5 years old die from RSV infections each year.The CDC committee also voted 11-0 to include the shot in Vaccines for Children, a federally funded program that provides vaccines to children whose families might otherwise not be able to afford them.The ACIPs unanimous recommendations for routine use of Beyfortus and inclusion in the Vaccines for Children program are critical steps toward providing millions of parents in the U.S. with the ability to protect their babies through their first RSV season, when they are most susceptible to severe RSV disease, said Thomas Triomphe, executive vice president of vaccines at Sanofi, in a statement.Sanofi will charge $495 per dose in the commercial market, according to slides presented at Thursdays meeting. The CDCs recommendation, alongside Beyfortus inclusion in the Vaccines for Children program, will allow the drug to be covered by insurance without a copay. Still, insurance coverage may take some months to be put in place.Beyfortus dosing is determined by an infants weight. Babies can receive either a 50 milligram, 100 milligram or 200 milligram dose. Pricing will be the same across dosage strengths, Sanofi said.While Beyfortus is being included in childrens vaccine initiatives, it is an antibody shot that provides passive immunization. Members of the committee noted how, because Beyfortus is a preventive treatment rather than a vaccine, parents will need to be educated to support uptake and counter hesitancy.A CDC-conducted survey, presented at the meeting, showed that 70% of respondents would definitely or probably give their newborns an RSV antibody treatment if it was safe and effective.Beyfortus is the only RSV antibody approved by the FDA for all infants under 18 months. Another antibody, Synagis, is available, but its use is limited to only certain infants who are high risk.Pfizer has developed a vaccine, named Abrysvo, that earlier this year won approval to prevent RSV infection in adults 60 years and older, who are also considered vulnerable to severe disease. The pharmaceutical giant is expecting a decision from the FDA soon on whether the vaccine could be used in pregnant people as a passive immunization for newborns.Committee members questioned whether it would be safe for an infant to later receive Beyfortus if their mother had previously been given Pfizers vaccine. Representatives for Sanofi deferred comment on any interaction between the two drugs.Should Pfizers shot be cleared for use during pregnancy, another ACIP meeting will be held to determine whether its safe for the vaccine and antibody to be used together.The European Medicines Agency backed Abrysvo for maternal use in July. An ongoing Phase 3b study is ongoing to further evaluate its safety and efficacy in infants, with more data one year after initial dosing.Wall Street analysts expect RSV vaccines and antibodies to eventually earn billions of dollars in yearly sales a lucrative market thats drawn other would-be competitors like Moderna. '

上市批准疫苗临床3期

2023-07-18

·Pharmaceutical Technology

FDA approves AstraZeneca’s RSV monoclonal antibody treatment for infants

Akosua Mireku @AkosuaMireku1 Prior to Beyfortus’ approval, the only approved RSV preventative antibody treatment for infants was AbbVie’s Synagis (palivizumab). Credit: GOLFX via Shutterstock The US Food and Drug Administration (FDA) has approved AstraZeneca and Sanofi’s Beyfortus (nirsevimab), a form of passive immunisation for infants born during or entering their first RSV season . Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report. The therapy can also be given to infants up to 24 months of age who are vulnerable to severe RSV disease through their second RSV season. Recommended Reports Reports LOA and PTSR Model - Monoclonal Antibody Conjugate to Target GPC1 for Oncology GlobalData Reports LOA and PTSR Model - Fully-Human Anti-CD19 Chimeric Antigen Receptor in Follicular Lymphoma GlobalData View all Companies Intelligence Pfizer Inc AbbVie Inc Sanofi AstraZeneca Plc GSK plc View all Beyfortus is an intramuscular monoclonal antibody therapy that acts by neutralising the RSV-F protein. This prevents the unfolding of the protein, blocking viral entry. The antibody’s approval is based on data from three clinical studies (trials 03, 04 and 05) and a positive recommendation from a 9 June FDA Advisory Committee meeting. The European Medicines Agency approved the prophylactic treatment in October 2022. Regulatory authorities in China, Japan and several other countries are also assessing the therapy. Prior to Beyfortus’ approval, the only approved RSV preventative antibody treatment for infants was AbbVie’s Synagis (palivizumab), which was approved in 1998. However, AstraZeneca ’s newly approved medicine is the first preventative option that specifically protects the broad infant population through its first RSV season. In a February 2023 email interview with Pharmaceutical Technology , Nancy Jaser, a senior infectious disease analyst at GlobalData, predicted that upon its approval, Beyfortus would replace Synagis as the standard of care passive immunisation for paediatric RSV patients. Beyfortus’s approval follows the FDA approval of the first RSV vaccine for older adults, GSK’s Arexvy. Patients aged 60 years and above are eligible to take the immunisation. This was followed a few weeks later by approval for Pfizer’s RSV vaccine Abrysvo, intended for the same population of individuals aged 60 years and above. Phase II data from Trial 03 (NCT02878330) demonstrated that infants treated with Beyfortus had a 6.9% lower incidence of medically attended RSV lower respiratory tract infection (MA RSV LRTI). It also demonstrated that Beyfortus decreased the risk of MA RSV LRTI by approximately 70% relative to placebo. In the Phase III (MELODY) Trial 04 (NCT03979313), this increased to 75% efficacy compared to placebo. Data was taken from the Phase II/III (MEDLEY) Trial 05 , showing that the drug had a favourable safety profile. GlobalData is the parent company of Pharmaceutical Technology. According to GlobalData, the only other RSV monoclonal antibody antiviral in Phase III trials is Merck’s clesrovimab. Merck is investigating the drug in a Phase II/III (NCT04767373) and a Phase III (NCT04938830) study. In a press release , AstraZeneca’s executive vice president Iskra Reic said: “Beyfortus represents an opportunity for a paradigm-shift in preventing serious respiratory disease due to RSV across a broad infant population in the US.” Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report.